Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

Condition(s) targeted: Peripheral Nerve Injury; Postherpetic Neuralgia

Intervention: CAPNP, 50 ug/cm2 capsaicin patch (Drug); CAPNP, 100 ug/cm2 capsaicin patch (Drug); 0.075% capsaicin cream (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Samyang Biopharmaceuticals Corporation

The efficacy and safety of the low concentration [0. 65% (50 µg/cm2) and 1. 25% (100 µg/cm2)] capsaicin patches and compared them to conventional 0. 075% capsaicin cream and placebo patch in patients suffering from peripheral neuropathy

Official title: Efficacy and Safety of 0.625% and 1.25% Capsaicin Patch in the Management of Peripheral Neuropathic Pain ; Early Phase II, Multi-center, Randomized, and Semi-double Blind Controlled Clinical Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean difference in the change of daily NRS pain score

Secondary outcome:

Percentage of patients with >=30% or >=50% reduction in pain

Daily Sleep Interference Scale

Clinical Global Impression for Improvement

EQ-5D

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients who are 18 years of age or older aged having chronic peripheral neuropathy

related with a diagnosis of either PHN or DPN

- patients with chronic peripheral neuropathic pain for more than 3 months with an

11-pointed Numeric Rating Scale (NRS) pain score ≥ 4

- patients with a diagnosis of PHN were eligible if at least 3 months had elapsed since

shingles vesicle crusting

- patients with DPN and well controlled diabetes were asked to maintain a stable dose

of oral hypoglycemic or insulin during the study period

- patients taking concomitant pain medications such as anticonvulsants,

antidepressants, anxiolytics, and opioids including tramadol were required to maintain a stable dose for at least 4 weeks before the study enrollment

- any conservative therapies such as TENS, physical therapy, chiropractic, massage,

biofeedback, or yoga were stopped at least 5 weeks before the enrollment

- women of childbearing age were required to have a negative pregnancy test and were to

be willing to use an effective method of contraception for at least 28 days after the last exposure to study medication Exclusion Criteria:

- diffusely distributed neuropathic pain resulting from spinal stenosis, postoperative

origin, complex regional pain syndrome, or genetic neurological disease, or significant pain outside the target area

- significant pain of an etiology other than PHN or DNP

- other severe acute or chronic medical or psychiatric condition, or laboratory

abnormality that may increase the risk associated with study participation or with investigational product administration or may interfere with compliance or the interpretation of study results andin the judgment of the investigator would make the subject inappropriate to participate in the study

- painful PHN areas located on the face or above the scalp hairline

- an implanted medical device for the treatment of neuropathic pain

- use of topically applied agents including capsaicin-containing products, a 5%

lidocaine patch or similar products, local anesthetics, or steroids within the past 21 days

- hypersensitivity known to capsaicin; current use of any class 1 anti-arrhythmic drug;

and uncontrolled diabetes mellitus or uncontrolled hypertension

- If patients have taken oral NSAID or COX2 Inhibitor, it should be stopped at least2

weeks before randomization; however acetaminophen for pain control was allowed up to 4g per day

Seoul National University Hospital, Seoula National University Bundang Hospital, Seoul, Korea, Republic of

Starting date: February 2009
Last updated: September 3, 2014